ID

12487

Description

CF-Patient, multicenter trial of hemolysis as diagnostic test for cystic fibrosis (HemCF) Principal Investigator PD Dr. Hermann Schillers, University Hospital of Mnster

Mots-clés

Versions (2)
  1. 13/11/2015 13/11/2015 -
  2. 23/11/2015 23/11/2015 -
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23 novembre 2015

DOI

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CF-Patient, multicenter trial of hemolysis as diagnostic test for cystic fibrosis (HemCF)

Allemand ( localization.languageCode.DE ) Anglais

CF-Patient, multicenter trial of hemolysis as diagnostic test for cystic fibrosis (HemCF)

1 Formulaires  
Patient Identification
Description

Patient Identification

Study site number
Description

Study site number

Type de données

integer

Alias
UMLS CUI [1]
C2825164
Patient number
Description

Patient number

Type de données

integer

Alias
UMLS CUI [1]
C1830427
Patient name
Description

Patient name

Type de données

text

Alias
UMLS CUI [1]
C1299487
Date of informed consent
Description

Date of informed consent

Type de données

date

Alias
UMLS CUI [1]
C2985782
inclusion criteria
Description

inclusion criteria

Existence of signed informed consent form
Description

Existence of signed informed consent form

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria
Description

exclusion criteria

Respiratory tract infections within past 4 weeks
Description

Respiratory tract infections within past 4 weeks

Type de données

boolean

Alias
UMLS CUI [1]
C0035243
Participation in investigational drug study within past 30 days
Description

Participation in investigational drug study within past 30 days

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
Clinical evidence of cystic fibrosis
Description

Clinical evidence of cystic fibrosis

Type de données

boolean

Alias
UMLS CUI [1]
C0010674
grouping
Description

grouping

Typical CF patient and delF508 homozygous
Description

Typical CF patient and delF508 homozygous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0010674
Typical CF patient without homozygous delF508
Description

Typical CF patient without homozygous delF508

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0010674
Atypical Cystic fibrosis patient
Description

Atypical Cystic fibrosis patient

Type de données

boolean

Alias
UMLS CUI [1,1]
C0010674
UMLS CUI [1,2]
C0205182
Date
Description

Date

Type de données

date

Alias
UMLS CUI [1]
C0011008
fecal elastase >200
Description

fecal elastase >200

Type de données

boolean

Alias
UMLS CUI [1]
C3203701
CFTR mutations
Description

CFTR mutations

CFTR mutations
Description

CFTR mutations

Type de données

boolean

Alias
UMLS CUI [1]
C2010866
Allele 1
Description

allele 1

Type de données

text

Alias
UMLS CUI [1]
C1633454
Allele 2
Description

allele 2

Type de données

text

Alias
UMLS CUI [1]
C1632238
Allele 1 and 2
Description

allele 1 and 2

Type de données

text

Alias
UMLS CUI [1,1]
C1633454
UMLS CUI [1,2]
C1632238
Other mutation allele 1
Description

Other mutation allele 1

Type de données

text

Alias
UMLS CUI [1]
C1633454
Other mutation allele 2
Description

Other mutation allele 2

Type de données

text

Alias
UMLS CUI [1]
C1632238
Shwachman-Score without x-ray
Description

Shwachman-Score without x-ray

Type de données

integer

sweat chloride
Description

sweat chloride

Type de données

text

Alias
UMLS CUI [1]
C1304760
Date
Description

date

Type de données

date

Alias
UMLS CUI [1]
C0011008
Date unknown
Description

date unknown

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0439673
Lung function tests
Description

Lung function tests

Pulmonary function test performed?
Description

Pulmonary function test performed?

Type de données

boolean

Alias
UMLS CUI [1]
C0024119
Date pulmonary function test
Description

Date pulmonary function test

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
FEV1
Description

FEV1

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C0748133
%
FVC
Description

FVC

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C1287681
%
demography
Description

demography

Date of birth
Description

Date of birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Type de données

text

Alias
UMLS CUI [1]
C0150831
Body weight
Description

body weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body height
Description

Body height

Type de données

float

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
hemolysis
Description

hemolysis

date of blood Collection
Description

date of blood Collection

Type de données

datetime

Alias
UMLS CUI [1,1]
C0190979
UMLS CUI [1,2]
C0011008
Laboratory Procedure Date
Description

Laboratory Procedure Date

Type de données

datetime

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Result Control 75
Description

Result Control 75

Type de données

float

Unités de mesure
  • %
%
Result GD3+
Description

Result GD3+

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1,1]
C2826772
UMLS CUI [1,2]
C0061105
%
Result Gd3+ and Zn2+
Description

Result Gd3+ and Zn2+

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1,1]
C2826772
UMLS CUI [1,2]
C0061105
UMLS CUI [1,3]
C2346521
%
Other laboratory results
Description

Other laboratory results

erythrocyte
Description

erythrocyte

Type de données

float

Unités de mesure
  • /μl
Alias
UMLS CUI [1]
C0014772
/μl
Vitamin E
Description

vitamin e

Type de données

float

Unités de mesure
  • mg/l
Alias
UMLS CUI [1]
C1142098
mg/l
reticulocytes
Description

reticulocytes

Type de données

float

Alias
UMLS CUI [1]
C0035286
unit used for testing reticulocytes
Description

unit used for testing reticulocytes

Type de données

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0206161
Zinc
Description

zinc

Type de données

float

Alias
UMLS CUI [1]
C0373748
unit used for testing zinc
Description

unit used for testing zinc

Type de données

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0373748
Concomitant medication past 4 weeks
Description

Concomitant medication past 4 weeks

no concomitant medication
Description

no concomitant medication

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
Inhalation Drug Administration
Description

Inhalation Drug Administration

Type de données

text

Alias
UMLS CUI [1]
C0001559
Per Os
Description

Per Os

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0039225
other concomitant medications
Description

other concomitant medications

Type de données

text

Alias
UMLS CUI [1]
C2347852
Date
Description

date

Type de données

date

Alias
UMLS CUI [1]
C0011008
Signature Investigator
Description

Signature Investigator

Type de données

text

Alias
UMLS CUI [1]
C2346576
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Similar models

CF-Patient, multicenter trial of hemolysis as diagnostic test for cystic fibrosis (HemCF)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient Identification
Study site number
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Patient name
Item
Patient name
text
C1299487 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C2985782 (UMLS CUI [1])
Item Group
inclusion criteria
Existence of signed informed consent form
Item
Existence of signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
exclusion criteria
Respiratory tract infections within past 4 weeks
Item
Respiratory tract infections within past 4 weeks
boolean
C0035243 (UMLS CUI [1])
Participation in investigational drug study within past 30 days
Item
Participation in investigational drug study within past 30 days
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Clinical evidence of cystic fibrosis
Item
Clinical evidence of cystic fibrosis
boolean
C0010674 (UMLS CUI [1])
Item Group
grouping
Typical CF patient and delF508 homozygous
Item
Typical CF patient and delF508 homozygous
boolean
C0011900 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
Typical CF patient without homozygous delF508
Item
Typical CF patient without homozygous delF508
boolean
C0011900 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
Atypical Cystic fibrosis patient
Item
Atypical Cystic fibrosis patient
boolean
C0010674 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
fecal elastase >200
Item
fecal elastase >200
boolean
C3203701 (UMLS CUI [1])
Item Group
CFTR mutations
CFTR mutations
Item
CFTR mutations
boolean
C2010866 (UMLS CUI [1])
Item
Allele 1
text
C1633454 (UMLS CUI [1])
allele 1
Code List
Allele 1
CL Item
delF508  (delF508 )
CL Item
N1303K  (N1303K )
CL Item
R117H (R117H)
CL Item
G551D  (G551D )
CL Item
R560T  (R560T )
CL Item
2184dA (2184dA)
CL Item
G542X  (G542X )
CL Item
dl507  (dl507 )
CL Item
R1162X (R1162X)
CL Item
R553X  (R553X )
CL Item
W1282X  (W1282X )
CL Item
A455E (A455E)
CL Item
1717-1G→A  (1717-1G→A )
CL Item
3849+10kb C→T (3849+10kb C→T)
CL Item
R347P S549N 621+1G→T (R347P S549N 621+1G→T)
Item
Allele 2
text
C1632238 (UMLS CUI [1])
allele 2
Code List
Allele 2
CL Item
delF508  (delF508 )
CL Item
N1303K  (N1303K )
CL Item
R117H (R117H)
CL Item
G551D  (G551D )
CL Item
R560T  (R560T )
CL Item
2184dA (2184dA)
CL Item
G542X  (G542X )
CL Item
dl507  (dl507 )
CL Item
R1162X (R1162X)
CL Item
R553X  (R553X )
CL Item
W1282X  (W1282X )
CL Item
A455E (A455E)
CL Item
1717-1G→A  (1717-1G→A )
CL Item
3849+10kb C→T (3849+10kb C→T)
CL Item
R347P S549N 621+1G→T (R347P S549N 621+1G→T)
Item
Allele 1 and 2
text
C1633454 (UMLS CUI [1,1])
C1632238 (UMLS CUI [1,2])
allele 1 and 2
Code List
Allele 1 and 2
CL Item
delF508  (delF508 )
CL Item
N1303K  (N1303K )
CL Item
R117H (R117H)
CL Item
G551D  (G551D )
CL Item
R560T  (R560T )
CL Item
2184dA (2184dA)
CL Item
G542X  (G542X )
CL Item
dl507  (dl507 )
CL Item
R1162X (R1162X)
CL Item
R553X  (R553X )
CL Item
W1282X  (W1282X )
CL Item
A455E (A455E)
CL Item
1717-1G→A  (1717-1G→A )
CL Item
3849+10kb C→T (3849+10kb C→T)
CL Item
R347P S549N 621+1G→T (R347P S549N 621+1G→T)
Other mutation allele 1
Item
Other mutation allele 1
text
C1633454 (UMLS CUI [1])
Other mutation allele 2
Item
Other mutation allele 2
text
C1632238 (UMLS CUI [1])
Shwachman-Score without x-ray
Item
Shwachman-Score without x-ray
integer
Item
sweat chloride
text
C1304760 (UMLS CUI [1])
sweat chloride
Code List
sweat chloride
CL Item
<30 mmol/l  (<30 mmol/l )
CL Item
>60 mmol/l (>60 mmol/l)
CL Item
≥30 und ≤60 mmol/l  (≥30 und ≤60 mmol/l )
date
Item
Date
date
C0011008 (UMLS CUI [1])
date unknown
Item
Date unknown
boolean
C0011008 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Item Group
Lung function tests
Pulmonary function test performed?
Item
Pulmonary function test performed?
boolean
C0024119 (UMLS CUI [1])
Date pulmonary function test
Item
Date pulmonary function test
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
FEV1
Item
FEV1
float
C0748133 (UMLS CUI [1])
FVC
Item
FVC
float
C1287681 (UMLS CUI [1])
Item Group
demography
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0150831 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
male (1)
CL Item
female (2)
body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Body height
Item
Body height
float
C0005890 (UMLS CUI [1])
Item Group
hemolysis
date of blood Collection
Item
date of blood Collection
datetime
C0190979 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Procedure Date
Item
Laboratory Procedure Date
datetime
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Result Control 75
Item
Result Control 75
float
Result GD3+
Item
Result GD3+
float
C2826772 (UMLS CUI [1,1])
C0061105 (UMLS CUI [1,2])
Result Gd3+ and Zn2+
Item
Result Gd3+ and Zn2+
float
C2826772 (UMLS CUI [1,1])
C0061105 (UMLS CUI [1,2])
C2346521 (UMLS CUI [1,3])
Item Group
Other laboratory results
erythrocyte
Item
erythrocyte
float
C0014772 (UMLS CUI [1])
vitamin e
Item
Vitamin E
float
C1142098 (UMLS CUI [1])
reticulocytes
Item
reticulocytes
float
C0035286 (UMLS CUI [1])
Item
unit used for testing reticulocytes
text
C1519795 (UMLS CUI [1,1])
C0206161 (UMLS CUI [1,2])
unit reticulocytes
Code List
unit used for testing reticulocytes
CL Item
% (1)
CL Item
/nl (2)
zinc
Item
Zinc
float
C0373748 (UMLS CUI [1])
Item
unit used for testing zinc
text
C1519795 (UMLS CUI [1,1])
C0373748 (UMLS CUI [1,2])
unit zinc
Code List
unit used for testing zinc
CL Item
μg/dl (1)
CL Item
μmol/l (2)
Item Group
Concomitant medication past 4 weeks
no concomitant medication
Item
no concomitant medication
boolean
C2347852 (UMLS CUI [1])
Item
Inhalation Drug Administration
text
C0001559 (UMLS CUI [1])
inhalation
Code List
Inhalation Drug Administration
CL Item
Colistin (Colistin)
CL Item
Tobramycin (Tobramycin)
CL Item
Dornase (Dornase)
CL Item
Salbutamol (Salbutamol)
CL Item
Salmeterol (Salmeterol)
CL Item
Formoterol (Formoterol)
CL Item
Budesonid (Budesonid)
CL Item
Fluticason/Salmeterol (Fluticason/Salmeterol)
CL Item
Ipratropiumbromid/Fenoterol (Ipratropiumbromid/Fenoterol)
CL Item
hypertonic saline solution (hypertonic saline solution)
Item
Per Os
text
C2347852 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
PO
Code List
Per Os
CL Item
Lipase, Amylase, (Lipase, Amylase,)
CL Item
Protease (Protease)
CL Item
Multivitamin (Multivitamin)
CL Item
Vitamin A (Vitamin A)
CL Item
Vitamin D (Vitamin D)
CL Item
Vitamin E (Vitamin E)
CL Item
Vitamin K (Vitamin K)
CL Item
Azithromycin (Azithromycin)
CL Item
Cefaclor (Cefaclor)
CL Item
Cefadroxil (Cefadroxil)
CL Item
Cefuroxim (Cefuroxim)
CL Item
Ciprofloxacin (Ciprofloxacin)
CL Item
Selenium (Selenium)
CL Item
Zinc (Zinc)
CL Item
Beta carotene (Beta carotene)
CL Item
trimethoprim (trimethoprim)
CL Item
sulfamethoxazole (sulfamethoxazole)
CL Item
ambroxole (ambroxole)
CL Item
N-Acetylcysteine (N-Acetylcysteine)
CL Item
Omeprazole (Omeprazole)
CL Item
UDCA (UDCA)
other concomitant medications
Item
other concomitant medications
text
C2347852 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Signature Investigator
Item
Signature Investigator
text
C2346576 (UMLS CUI [1])
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